Study on the clinical effect and mechanism of Shengyang Yiwei Decoction in regulating intestinal microflora to improve spleen deficiency type 2 diabetes
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摘要:
目的 研究升阳益胃汤对脾虚型2型糖尿病(T2DM)患者的临床疗效，并探讨其作用机理与肠道菌群的相关性。 方法 严格按照纳入、排除标准收集2022年9月—2023年8月浙江中医药大学附属第三医院收治的脾虚型T2DM患者共60例，采用随机数字表法分为2组，各30例，对照组采用西医常规治疗(口服降糖药或皮下注射胰岛素)，观察组在此基础上加用升阳益胃汤，治疗周期为8周。检测2组空腹血糖(FPG)、餐后2 h血糖(2hPG)、糖化血红蛋白(HbA1c)水平变化，采用16S rDNA方法检测肠道菌群变化，通过中医证候积分变化评价临床疗效。 结果 (1) 观察组患者治疗后总有效率(90.00%，27/30)高于对照组(66.67%，20/30，χ2=4.812, P=0.028)，中医证候积分低于对照组(P < 0.01)。(2)2组患者治疗后FPG、2hPG、HbA1c水平显著降低，观察组低于对照组(P < 0.01)。(3)Alpha多样性和Beta多样性分析发现，治疗后观察组较对照组物种丰富度、多样性升高更多(P < 0.05)，肠道菌群结构差异较大，其中变形杆菌属(Proteus)、摩氏摩根菌属(Morganella)、克雷伯菌属(Klebsiella)丰度增高显著(P < 0.05)。 结论 升阳益胃汤可有效改善脾虚型T2DM的血糖指标、中医证候表现，其作用机理与调节肠道菌群紊乱相关。 Abstract:Objective To explore the clinical efficacy of Shengyang Yiwei Decoction on type 2 diabetes mellitus (T2DM) patients with spleen deficiency, and discuss the correlation between its mechanism and intestinal flora. Methods Adhering closely to specific criteria, we enrolled 60 patients at the Third Affiliated Hospital of Zhejiang Chinese Medical University from September 2022 to August 2023 diagnosed with spleen deficiency-related T2DM and randomized them into two groups of 30 each using random number table method. The control group was administered standard Western therapy, including oral hypoglycemic drugs or insulin injections, on this basis, the experimental group was treated with Shengyang Yiwei Decoction, with a treatment cycle of 8 weeks. The changes in fasting plasma glucose (FPG), 2-hour post-load blood glucose (2hPG), glycated hemoglobin A1c (HbA1c) levels were detected by blood indicators, the changes in intestinal microbiota were detected using the 16S rDNA method, and the clinical curative effect was evaluated by the integral change of traditional Chinese medicine (TCM) syndrome. Results (1) The total effective rate of the experimental group patients after treatment was (90.00%, 27/30), which was higher than that of the control group (66.67%, 20/30, χ2=4.812, P=0.028), the score of TCM syndrome was lower than that of the control group (P < 0.01). (2) Both groups experienced significant decreases in FPG, 2hPG, and HbA1c levels after treatment, with the experimental group showing lower levels than the control group (P < 0.01). (3) Alpha diversity and Beta diversity analysis revealed that the experimental group showed a greater increase in species richness and diversity compared to the control group after treatment (P < 0.05), with significant differences in intestinal microbiota structure. Among them, the abundance of Proteus, Morchella, and Klebsiella increased significantly (P < 0.05). Conclusion Shengyang Yiwei Decoction is effective in improving blood glucose indicators and TCM syndrome manifestations of spleen deficiency type T2DM, with its mechanism being related to regulating intestinal flora disorders. -
图 1 2组2型糖尿病患者治疗前后肠道菌群Alpha多样性比较(Shannon、Pielou-e指数)
注：A为观察组治疗前；B为对照组治疗前；C为观察组治疗后；D为对照组治疗后。aP < 0.05，bP < 0.01，cP>0.05。
Figure 1. Comparison of Alpha diversity of intestinal flora in two groups of type 2 diabetes patients pre- and post- treatment (Shannon and Pieloue indices)
图 2 2组2型糖尿病患者治疗前后肠道菌群主坐标分析比较(PCoA)
注：A为观察组治疗前；B为对照组治疗前；C为观察组治疗后；D为对照组治疗后。
Figure 2. Principal coordinate analysis and comparison of intestinal flora pre- and post- treatment (PCoA) in two groups of type 2 diabetes patients
图 3 气泡图分析不同分组中肠道菌群组成(门属水平)
注：A为观察组治疗前；B为对照组治疗前；C为观察组治疗后；D为对照组治疗后。
Figure 3. Bubble plot of gut microbiota composition across study groups (phylum level)
表 1 2组2型糖尿病患者中医证候临床总有效率比较[例(%)]
Table 1. Comparison of the overall clinical efficacy of TCM syndrome differentiation in the two groups of patients with type 2 diabetes[cases (%)]
组别 例数 显效 有效 无效 总有效 对照组 30 7(23.33) 13(43.33) 10(33.33) 20(66.67) 观察组 30 12(40.00) 15(50.00) 3(10.00) 27(90.00) 注：2组总有效率比较，χ2=4.812，P=0.028。 
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表 2 2组2型糖尿病患者治疗前后中医证候积分比较(x±s，分)
Table 2. Comparison of TCM syndrome scores pre- and post-treatment in two groups of patients with type 2 diabetes(x±s)
组别 例数 治疗前 治疗后 t值 P值 对照组 30 14.90±2.67 7.93±3.29 9.006 < 0.001 观察组 30 15.63±3.43 5.96±3.07 11.507 < 0.001 统计量 0.924a 8.262b P值 0.359 0.006 注：a为t值，b为F值。
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表 3 2组2型糖尿病患者治疗前后FPG、2hPG、HbA1c比较(x±s)
Table 3. Comparison of FPG, 2hPG, and HbA1c pre- and post- treatment in two groups of patients with type 2 diabetes(x±s)
组别 例数 FPG(mmol/L) 2hPG(mmol/L) HbA1c(%) 治疗前 治疗后 治疗前 治疗后 治疗前 治疗后 对照组 30 9.39±2.21 6.18±1.19b 10.79±2.18 7.64±1.27b 7.82±1.14 6.31±0.58b 观察组 30 9.47±3.39 5.57±1.08b 10.92±3.37 7.02±1.03b 7.73±1.15 5.76±0.83b 统计量 0.116a 8.657c 0.179a 8.983c 0.322a 8.838c P值 0.908 0.005 0.859 0.004 0.749 0.004 注：a为t值，c为F值。与同组治疗前比较，bP < 0.01。
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